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Industry

Across R&D, quality
and regulatory

In regulated work the evidence trail is part of the deliverable. It is also distributed across validated systems that cannot simply be merged.

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  1. Source 01 Study records
  2. Source 02 Submissions
  3. Source 03 Deviations and CAPAs
  4. Source 04 Batch records

The problem

Your evidence already exists. It is fragmented across validated systems.

Each system is validated, controlled and correct on its own terms. That is precisely why the connections between them are missing: nothing is allowed to reach across, so people do it manually and the trail is rebuilt each time it is needed.

An example question, answered from four connected sources Asked: Which batches were made after deviation DEV-1187 was raised? Answer: Four batches. CAPA-092 closed the deviation, and batch 24-031 is cited in the open submission. Sources: Stability study S-12 (study records), Submission, module 3 (submissions), DEV-1187 and CAPA-092 (deviations and capas), Batches 24-028 to 031 (batch records). Which batches were made after deviation DEV-1187 was raised?| STUDIO EXAMPLE Four batches. CAPA-092 closed the deviation, and batch 24-031 iscited in the open submission. SOURCES STUDY RECORDS Stability study S-12 SUBMISSIONS Submission, module 3 DEVIATIONS AND CAPAS DEV-1187 and CAPA-092 BATCH RECORDS Batches 24-028 to 031
An example question, answered from four connected sources Asked: Which batches were made after deviation DEV-1187 was raised? Answer: Four batches. CAPA-092 closed the deviation, and batch 24-031 is cited in the open submission. Sources: Stability study S-12 (study records), Submission, module 3 (submissions), DEV-1187 and CAPA-092 (deviations and capas), Batches 24-028 to 031 (batch records). Which batches were made after deviationDEV-1187 was raised?| STUDIO EXAMPLE Four batches. CAPA-092 closed thedeviation, and batch 24-031 is cited inthe open submission. SOURCES STUDY RECORDS Stability study S-12 SUBMISSIONS Submission, module 3 DEVIATIONS AND CAPAS DEV-1187 and CAPA-092 BATCH RECORDS Batches 24-028 to 031

What changes

Connect submissions, evidence and commitments

01

Submissions

What was committed to, in which submission, and what demonstrates it.

02

Deviations and CAPAs traced

Followed through change control to the evidence that the action was effective.

03

Prior evidence found

Study records and past evidence located without knowing which program generated them.

In practice

Connected without being merged

The graph references the validated systems. It does not replace them, and it does not move the records.

  1. 01

    Records stay in place

    The system of record keeps its role, its validation and its audit trail.

  2. 02

    Permissions inherited

    Access follows the source system, per record, at query time.

  3. 03

    Everything logged

    Every query and access recorded, which in this sector is the baseline, not a feature.

Security

Built for security

Made in Germany and built for data sovereignty. Your data stays in your environment, encrypted and access controlled down to the individual record.

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On premises or private cloud

Deploy on your own infrastructure or in certified data centers in Europe.

Single sign on and enforced MFA

Access synced to your data sources with relationship based permissions.

Full audit trail

Every query, download and data access logged.

Data residency

Your data stays in the region you choose.

Made in Germany

Built in Munich.

GDPR compliant

European data protection standards.

Your data. Your infrastructure.

Connected evidence across the estate

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